Phase 2
Completed N=43
Veliparib, Bendamustine Hydrochloride, and Rituximab in Treating Patients With Relapsed or Refractory Lymphoma, Multiple Myeloma, or Solid Tumors
Source: ClinicalTrials.gov NCT01326702 ↗Enrolled (actual)
43
Serious AEs
44.2%
Results posted
Dec 2019
Primary outcomePrimary: Maximum Tolerated Dose of Veliparib When Combined With Bendamustine Hydrochloride — 300 mg
Summary
This phase I/II trial studies the side effects and the best dose of veliparib when given together with bendamustine hydrochloride and rituximab and to see how well they work in treating patients with lymphoma, multiple myeloma, or solid tumors that have come back or have not responded to treatment. Veliparib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as bendamustine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and help kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Giving veliparib together with bendamustine hydrochloride and rituximab may kill more cancer cells.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Tolerated Dose of Veliparib When Combined With Bendamustine Hydrochloride |
300 | — |
| PRIMARY Response Rate |
0; 0; 1; 0; 0; 4 | — |
| PRIMARY Number of Participants With Adverse Events |
3; 3; 4; 2; 2; 5 | — |
| SECONDARY Complete Response (CR) to Study Treatment (Phase IIa) |
5 | — |
| SECONDARY Duration of Remission (Phase IIa) |
— | — |
| SECONDARY Overall Survival (Phase IIa) |
— | — |
| SECONDARY Pharmacokinetic Parameters of Veliparib (Phase Ib) |
1.79; 3.58; 7.93; 12.6; 16.9; 19.0 | — |
| SECONDARY Progression-free Survival Using RECIST Version 1.1 (Phase IIa) |
14.2 | — |
| SECONDARY Participants With Dose Limiting Toxicities |
0; 0; 1; 0; 0; 1 | — |
Eligibility Criteria
Inclusion Criteria
- Phase 1b: Patients must have a histologically confirmed solid malignancy, lymphoma or multiple myeloma for which standard curative or palliative measures do not exist, are no longer effective, or for which the patient is not eligible or refuses; phase 1b cohort expansion: patients must have a histologically confirmed cluster of differentiation (CD)-20 positive B-cell non-Hodgkin lymphoma for which standard curative or palliative measures do not exist, are no longer effective, or for which the patient is not eligible or refuses; phase 2a: patients must have histologically or cytologically confirmed marginal zone B-cell lymphoma, small lymphocytic lymphoma, lymphoplasmacytic lymphoma or mantle cell lymphoma, and must have at least one measureable site of disease
- For lymphoma and multiple myeloma patients: patients who have relapsed or are refractory to at least one prior chemotherapeutic regimen or biologic agent; patients must either be ineligible for or have refused curative options for treatment, including stem cell transplant, if applicable
- For solid tumor patients: relapsed or refractory to at least one prior chemotherapeutic regimen or biologic agent; patients must either be ineligible for or have refused curative options for treatment
- Patients must have had a rest period of at least 3 weeks since prior chemotherapy or radiation therapy, 6 weeks if the last regimen included carmustine (BCNU) or mitomycin C; there must be a rest period of at least 3 months if the last therapy was immunotherapy or radioimmunotherapy (unless the disease has progressed since treatment)
- Eastern Cooperative Oncology Group (ECOG) performance status = = 60%)
- Life expectancy of greater than 3 months
- Absolute neutrophil count (ANC) >= 1,000/mcL
- Platelets >= 100, 000/mcL unsupported by transfusion within the prior 2 weeks
- Hemoglobin >= 8.0 g/dL unsupported by transfusion within the prior 2 weeks
- Total bilirubin = = 60 mL/min for patients with creatinine levels above institutional normal
- Patients with prior stem cell transplant will be eligible as long as they have not relapsed or progressed within 100 days post-transplant and they meet the above inclusion criteria
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal, barrier method of birth control, or abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
- Ability to understand and the willingness to sign a written informed consent document
- Toxicities from prior therapies must have resolved to baseline, or be = 3 months and off steroid treatment prior to study enrollment
Exclusion Criteria
- Patients who have had chemotherapy or radiotherapy within 3 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered to baseline (or are not at stable grade = = 4 weeks, as long as the CD4 count is > 300; appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated; patients on zidovudine or stavudine would not be eligible
- Patients with active seizure or a history of seizure are not eligible
- Patients with uncontrolled CNS metastasis are not eligible
- Patients with unrelated prior malignancies must have undergone potentially curative therapy for their prior malignancy, have no evidence of that disease for three years, or be deemed at low risk for recurrence of their prior malignancy by her/his treating physician; patients with dermal squamous cell carcinoma, basal cell carcinoma or melanoma in situ that has been completely excised will be eligible following excision
Data sourced from ClinicalTrials.gov (NCT01326702). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.